Safety

Injection Site Reactions

PERSERIS—a once-monthly subcutaneous long-acting injectable (LAI)1

After subcutaneous injection, a majority of patients reported no injection pain (≥75%), no tenderness (≥79%), no erythema (≥92%), and no inflammation (≥88%) after receiving PERSERIS in an 8-week, Phase III study.1

Less than 1% of patients reported moderate tenderness at any time point, and 1 patient reported severe tenderness. Additionally, 1 or 2 patients reported cases of moderate pain, erythema, and inflammation/swelling1

Mean injection site pain scores in a 12-month extension study (EXT)2

Injection site pain was measured using the Visual Analog Scale (VAS)(0=no pain to 100=unbearably painful)1

All patients

Patients who received 11 injections

Time post-injection

Injection 1-EXT(N=500)

Injection 1-EXT(N=248)

Injection 11-EXT(N=248)

1 minute

24.9

25.6

15.8

5 minutes

11.2

10.7

7.2

30 minutes

5.6

5.4

3.9

60 minutes

4.2

4.6

3.3

Injections were measured from the start of the 12-month EXT. Rollover patients received 2 prior injections of PERSERIS.2

In a 12-month extension study, the most common injection site reactions for all patients were injection site pain (13%), injection site nodule (7%), injection site induration (6%), and injection site pruritus (5%)2

*De novo run-in patients (those who were not already receiving oral risperidone) were titrated off any current antipsychotic medication and onto oral risperidone (3 mg or 4 mg daily) at the investigator’s discretion during the run-in phase (Days -14 to -3).2

†De novo conversion patients (those who were currently receiving oral risperidone at a dose other than 3 or 4 mg daily) were titrated onto oral risperidone (3 mg or 4 mg daily) during the conversion phase (Days -7 to -3).2

‡De novo patients who were already receiving 3 mg or 4 mg of oral risperidone daily did not complete the run-in or conversion phase. After eligibility was confirmed, they began the study on Day 1.2

The study evaluated the long-term safety and tolerability of PERSERIS in 500 patients with schizophrenia2

The primary objective was to assess the long-term safety and tolerability of PERSERIS2

A one-time down-titration to 90 mg was allowed per investigator discretion. Subjects receiving 90 mg PERSERIS who exhibited worsening psychiatric symptoms could receive a one-time up-titration back to 120 mg PERSERIS at the discretion of the investigator2

The study evaluated the efficacy, safety, and tolerability of PERSERIS in 337 inpatients between the ages of 18 and 55 with acute exacerbations of schizophrenia1

Patients were eligible for inclusion in the study if they had PANSS total scores of 80 to 120 at screening, without an improvement ≥20% between screening and the first dosing day. Patients had an average PANSS total score of 94 to 96 between the groups1

Tolerability to oral risperidone was established prior to treatment1

Patients who completed the study had the option of entering a 12-month safety extension study3

The primary endpoint was the change in PANSS total scores from baseline to Day 571

IMPORTANT SAFETY INFORMATION

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. PERSERIS is not approved for the treatment of patients with dementia-related psychosis and has not been studied in this population.

INDICATIONS AND USAGE

PERSERIS is indicated for the treatment of schizophrenia in adults.

CONTRAINDICATIONS:

PERSERIS is contraindicated in patients with a known hypersensitivity to risperidone, its metabolite, paliperidone, or to any of its components. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone or paliperidone.

WARNINGS AND PRECAUTIONS

Cerebrovascular Adverse Reactions: In trials of elderly patients with dementia-related psychosis, there was a significantly higher incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack), including fatalities, in patients treated with oral risperidone compared to placebo. PERSERIS is not approved for use in patients with dementia-related psychosis.

Tardive Dyskinesia (TD): TD may develop in patients treated with antipsychotic drugs. The risk of developing TD and likelihood that it will become irreversible are believed to increase with treatment duration and total cumulative dose. Less commonly, TD can develop after relatively brief treatment periods at low doses. Elderly patients, especially elderly women, appear to be at increased risk, but it is impossible to predict which patients will develop TD. Therefore, PERSERIS should be prescribed in a manner that is most likely to minimize the occurrence of TD. Discontinue treatment if clinically appropriate.

Metabolic Changes that may increase cardiovascular/cerebrovascular risk, have been associated with atypical antipsychotics (APs).

Hyperglycemia and Diabetes Mellitus (DM), in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, have been reported in patients treated with APs, including risperidone. Patients with DM who are started on atypical APs, including PERSERIS, should be monitored regularly for worsening of glucose control. Patients at risk for DM (e.g., obesity, family history of diabetes) who are starting treatment with atypical APs, including PERSERIS, should undergo fasting blood glucose (FBG) testing at the beginning of treatment and periodically while treated. Any patient treated with atypical APs, including PERSERIS, should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia during treatment with atypical APs, including PERSERIS, should undergo FBG testing. In some cases, hyperglycemia has resolved when risperidone was discontinued; however, some patients required continuation of antidiabetic treatment despite discontinuation of risperidone.

Dyslipidemia has been observed in patients treated with atypical APs.

Weight Gain has been observed with atypical AP use. Monitoring weight is recommended.

Hyperprolactinemia: Risperidone elevates prolactin levels, and the elevation persists during chronic administration. Risperidone is associated with higher levels of prolactin elevation than other antipsychotic agents. Hyperprolactinemia may inhibit reproductive function in female and male patients. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported in patients receiving prolactin-elevating drugs. Long-standing hyperprolactinemia, when associated with hypogonadism, may lead to decreased bone density in females and males.

Orthostatic Hypotension: Risperidone may induce orthostatic hypotension associated with dizziness, tachycardia, and in some patients, syncope. Use with particular caution in patients with known cardiovascular disease, cerebrovascular disease, and conditions which predispose patients to hypotension, and in the elderly and patients with renal or hepatic impairment. Monitor such patients and consider a dose reduction if hypotension occurs.

Falls: Somnolence, postural hypotension, motor instability, and sensory instability have been reported with the use of antipsychotics, including PERSERIS, which may lead to falls, and consequently, fractures or other fall-related injuries. Assess the risk of falls when initiating treatment and recurrently during treatment.

Leukopenia, Neutropenia, and Agranulocytosis have been reported with antipsychotic agents, including risperidone. In patients with a history of a clinically significant low white blood count (WBC) or a drug-induced leukopenia/neutropenia, perform a complete blood count frequently during the first few months of therapy. Consider discontinuation at the first sign of a clinically significant decline in WBC in the absence of other causative factors. Monitor patients with clinically significant neutropenia for fever or other symptoms/signs of infection and treat promptly if such symptoms/signs occur. Discontinue PERSERIS in patients with severe neutropenia (absolute neutrophil count <1000/mm3) and follow WBC until recovery.

Potential for Cognitive and Motor Impairment: Risperidone may impair judgment, thinking, or motor skills. Caution patients about operating machinery, including automobiles, until they are reasonably certain PERSERIS does not affect them adversely.

Seizures have been observed in risperidone studies in adults with schizophrenia. PERSERIS should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold.

Dysphagia: Esophageal dysmotility and aspiration can occur. Use cautiously in patients at risk for aspiration pneumonia.

Priapism has been reported with other risperidone products. Severe priapism may require surgical intervention.

Disruption of Body Temperature Regulation has been attributed to antipsychotic agents. Use with caution in patients who will be exposed to temperature extremes.

Adverse Reactions:

The most common adverse reactions in a clinical trial (≥ 5% and greater than placebo) were increased weight, constipation, sedation/somnolence, pain in extremity, back pain, akathisia, anxiety, and musculoskeletal pain. The most common injection site reactions (≥ 5%) were injection site pain and erythema. This is not a complete list of potential adverse events. Please see the full Prescribing Information for a complete list.

Use with other CNS drugs or alcohol may increase nervous system disorders.

PERSERIS may enhance hypotensive effects of hypotensive agents.

PERSERIS may antagonize the pharmacologic effects of dopamine agonists.

USE IN SPECIFIC POPULATIONS

Pregnancy: PERSERIS may cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure. Advise patients to notify their healthcare professional if they become or intend to become pregnant during treatment with PERSERIS. Patients exposed to PERSERIS during pregnancy may be registered with the National Pregnancy Registry for Atypical Antipsychotics (1-866-961-2388 or http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/).

Lactation: Infants exposed to risperidone through breastmilk should be monitored for excess sedation, failure to thrive, jitteriness, and extrapyramidal symptoms.

Pediatric Use: Safety and effectiveness of PERSERIS have not been established in pediatric patients.

Renal or Hepatic Impairment: Carefully titrate on oral risperidone up to at least 3 mg before initiating treatment with PERSERIS at a dose of 90 mg.

To report pregnancy or side effects associated with taking PERSERIS, please call 1-877-782-6966.

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P-RAG-US-00126

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